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07【参考資料２】FDA Statement Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses（June 30, 2022） (3 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_26922.html |
| 出典情報 | 厚生科学審議会 予防接種・ワクチン分科会（第33回 7／22）《厚生労働省》 |
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vaccines containing an omicron BA.4/5 component, as these data will be of use as
2
the pandemic further evolves.
3
4
The FDA has been planning for the possibility that vaccines would need to be
5
modified to address circulating variants and previously provided guidance to
6
industry on how to do so efficiently. As has been the case with all COVID-19
7
vaccines throughout the pandemic, the agency will evaluate all relevant data to
8
inform the safety, effectiveness and manufacturing quality of modified vaccines
9
under consideration for authorization or approval to ensure that they meet the
10
FDA’s standards.
11
12
In keeping with our commitment to transparency, the FDA will communicate
13
future plans pertaining to the potential authorization or approval of COVID-19
14
vaccine booster doses with an omicron component.
15
16
###
17
18
19
The FDA, an agency within the U.S. Department of Health and Human Services,
20
protects the public health by assuring the safety, effectiveness, and security of
21
human and veterinary drugs, vaccines and other biological products for human
22
use, and medical devices. The agency also is responsible for the safety and security
23
of our nation’s food supply, cosmetics, dietary supplements, products that give off
24
electronic radiation, and for regulating tobacco products.
3
vaccines containing an omicron BA.4/5 component, as these data will be of use as
2
the pandemic further evolves.
3
4
The FDA has been planning for the possibility that vaccines would need to be
5
modified to address circulating variants and previously provided guidance to
6
industry on how to do so efficiently. As has been the case with all COVID-19
7
vaccines throughout the pandemic, the agency will evaluate all relevant data to
8
inform the safety, effectiveness and manufacturing quality of modified vaccines
9
under consideration for authorization or approval to ensure that they meet the
10
FDA’s standards.
11
12
In keeping with our commitment to transparency, the FDA will communicate
13
future plans pertaining to the potential authorization or approval of COVID-19
14
vaccine booster doses with an omicron component.
15
16
###
17
18
19
The FDA, an agency within the U.S. Department of Health and Human Services,
20
protects the public health by assuring the safety, effectiveness, and security of
21
human and veterinary drugs, vaccines and other biological products for human
22
use, and medical devices. The agency also is responsible for the safety and security
23
of our nation’s food supply, cosmetics, dietary supplements, products that give off
24
electronic radiation, and for regulating tobacco products.
3